Beta blocker use in traumatic brain injury based on the high-sensitive troponin status (BBTBBT): methodology and protocol implementation of a double-blind randomized controlled clinical trial

Table 1 BBTBBT timeline

Procedure/intervention/task	Day 1	Day 2	Day 3	Day 4	Day 5	Day 6	3-month
Selection criteria¹	X
Informed consent	X
CT scan head²	X
HsTnT³	X
Vital signs⁴	X	X	X	X	X	X
Randomization	X
Treatment protocol⁵	X	X	X	X	X	X
Electrocardiography (ECG)	X	X
Echocardiography⁶	X
Laboratory tests (S100B, enolase, cytokines (IL-1b,6,8,18))	X	X	X
Serum epinephrine	X	X
Routine blood tests⁷	X
Glasgow Outcome Score (GOS)							X
Last day follow-up							X

1 = on admission, 2 = on-admission if hemodynamically stable and head injury suspected, 3= within 4 h and to repeat after 6 h, 4= continuous monitoring and to be documented before starting treatment, 5 = beta blocker vs. placebo within the 1st 24 h of admission, 6 = if troponin positive and ECG changes,7 = blood hemoglobin, platelet count, international normalized ratio, prothrombin time, activated partial thromboplastin time, blood glucose level, C-reactive protein, serum creatinine, urea, lactate, base deficit, sodium, and potassium, * = outcome (alive vs. dead)

ISSN: 1745-6215